| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00346-1 |
| Product Name/Description |
AlignRT Plus
Multiple Serial Numbers
AlignRT
UDI number: 5056190500337
AlignRT Offline
UDI number: 5056190500610
ARTG 270213
(Vision RT Australia Pty Ltd - Patient positioning/tracking video camera system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
A change to the Australian Sponsor was made in June 2020. This change resulted in updated labelling with the new Australian Sponsor information.
An incorrect Australian Sponsor label was applied to all workstations of AlignRT Plus that were shipped to Australia after June 2020.
Labels which contain information of a previous Australian Sponsor were applied instead of the current version of the labels. The Instructions for Use is not affected, this includes the correct most update information.
This issue is relating to labelling only. It does not impact the safety, efficacy or performance concerns to the end user or patient. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
For customers with a service contract:
The labels with the old sponsor information will be removed and replaced with the correct information on the next preventative maintenance visit by Vision RT Australia.
For customers without a service contract:
Vision RT Australia will supply the correct label, and instructions on how to remove the existing label and replace with the correct one are detailed in images in the customer letter, supplied to affected customers.
This action has been finalised on 30/7/2024. |
| Contact Information |
0420 602 143 - Sue McKenna, Director of Clinical Applications – APAC |